POSITION SUMMARY:
Primary responsibility is to serve as a member of the project team with the lead responsibility for reviewing CRFs, data listings, and databases to ensure that all captured data follow the rules outlined by the protocol and data management plan. Also responsible for the preparation of data management plans, data entry guidelines, data management reports and other documents required for preparing and completing databases. Where a Biometrics Project Manager is allocated on a study, acts as the Data Operations point of contact for all data management responsibilities when designated as the Data Management Team Leader (Core Team Representative).
PRIMARY JOB FUNCTIONS:
Coordinates and acts as point of contact for all data operations responsibilities related to data management for multiple studies when designated as the Data Management Team Leader for the Premier Research project team
Prepares data management plans, data entry guidelines, data management reports and other documents required for preparing and completing databases, when requested
Reviews draft protocols and CRFs for potential data collection and representation, database structure or data entry problems, and provides feedback to the project team, when requested
Reviews CRFs, data listings, and database to ensure all captured data follow the rules outlined by the protocol and data management plan
Generates paper and electronic queries to appropriate internal or external personnel (investigational sites, vendors, Clinical Research Associates (CRAs), client representatives) to resolve problematic data identified during every aspect of the data management process
Reviews responses to queries for appropriateness, resolves any discrepancies and modifies the database accordingly
Reconciles 3 rd party data with CDMS data.
Provides coaching, support and mentoring to less experienced team members in data management practices and related technical issues
Reviews & contributes to the development/update of department SOP’s and Working Guidelines
Leads/participates in task force groups that impact on the team
Participates in project costing estimates and proposal review in the business development/change order process
Participates in Proposal Defense and Capabilities presentations
Tracks CRFs as they are processed through the Data Management department
If assigned, interacts with the Biometrics Project Manager on a continual basis throughout the course of the study
All other projects as assigned
OTHER RESPONSIBILITIES:
Quality control reviews output of the clinical database (entry screens or data listings) against primary documents (e.g., data management plan, case report forms and queries) for data accuracy, consistency and application of predetermined conventions
Assists in writing quality control reports in a timely and concise manner according to PRG standard operating procedures
Ability to perform overnight business travel, up to 10%
May develop CRF’s eCRF’s or annotated CRF’s
May code medical terms in accordance with coding conventions
Required Skills
EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:
Educated to Bachelor’s degree level or equivalent. In lieu of this qualification, 3 years experience in clinical research, drug development or healthcare environment will be required
In addition to this a minimum of 8 years data management experience
Alternatively, must already have extensive experience in all primary job functions
Understanding and experience with up to date MS Windows Operating Systems and applications and at least one Database Management System (e.g., SAS, Oracle, Clintrials, Oracle Clinical, eDM, etc.)
Attentive to details and able to independently resolve a variety of issues without close supervision
Organisation & Planning skills
Enjoys working collaboratively as part of a team
Working knowledge of medical terminology
Fluent English Communication skills (verbal, written & interpersonal)
Excellent Customer relation skills
Capable of handling multiple priorities
Required Experience
Premier Research - 30+ days ago
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